BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Easy Step Control Solution - LOW

    DI: 00891237001225 · Model: T506-65 · HOME AIDE DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Easy Step Control Solution - LOW
    Primary DI
    00891237001225
    Version / Model
    T506-65
    Catalog Number
    1225
    Company Name
    HOME AIDE DIAGNOSTICS, INC.
    Labeler DUNS
    783518983
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-05-01
    Public Version
    4
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    9f2f14ef-7d8a-4a70-99f2-7469ba8da08a

    Device Description

    Blood glucose control solution for use with Easy Step blood glucose testing system

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    41819 Glucose IVD, control

    Identifiers

    Type ID
    Primary 00891237001225
    Package 20891237001229
    Package 30891237001226

    Customer Contacts

    Phone
    1-800-915-0116
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K090629 000

    Device Sizes

    Type Value Unit Text
    Total Volume 3 Milliliter

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Store at temperatures between 39-86oF (4-30oC).